PART 1General

Definition

Definition of Minister

1 In these Regulations, Minister means the Minister of Health.

Purpose

Marginal note:Purpose — fees

• 2 (1) The purpose of these Regulations is to prescribe the fees for

  • (a) the examination of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission referred to in section C.08.002, C.08.002.1 or C.08.003 of the Food and Drug Regulations, an application in respect of an establishment licence under those Regulations or an application for a drug identification number under section C.01.014.1 of those Regulations;

  • (b) the examination of an application for, or the renewal of, a dealer’s licence under Part G of the Food and Drug Regulations or under the Narcotic Control Regulations;

  • (c) the right to sell a drug under the Food and Drug Regulations; and

  • (d) the examination of an application in respect of a medical device licence, the right to sell a medical device or the examination of an application in respect of an establishment licence under the Medical Devices Regulations.

• Marginal note:Purpose — remission

  (2) The purpose of these Regulations is also to remit, in whole or in part, certain of those fees.

Application

Marginal note:Non-application

3 These Regulations do not apply in respect of

• (a) a drug that is proposed for veterinary use only; or

• (b) a drug that is a natural health product.

Annual Adjustment of Fees

Marginal note:Adjustment of fees

4 Every fee set out in these Regulations is to be increased annually by 2%, rounded up to the nearest dollar, beginning on April 1, 2012.

PART 2Drugs

DIVISION 1Fees for the Examination of a Drug Submission

Interpretation

Marginal note:Definitions

• 5 (1) The following definitions apply in this Division.

  actual gross revenue

  actual gross revenue means the amount earned by the person referred to in section 6 during the fee verification period from the sales in Canada of the drug that is the subject of a submission, a supplement or an application referred to in that section. (recettes brutes réelles)

  anticipated gross revenue

  anticipated gross revenue means the amount that the person referred to in section 6 expects to earn during the fee verification period from the sales in Canada of the drug that is the subject of a submission, a supplement or an application referred to in that section. (recettes brutes prévues)

  fee verification period

  fee verification period, in respect of a drug that is the subject of a submission, a supplement or an application referred to in section 6, means the period beginning on the day on which the drug is first sold in Canada after a notice of compliance is issued in respect of the submission or supplement or after a drug identification number is assigned for the drug as a result of the application and ending three years after that day. (période de vérification du prix à payer)

• Marginal note:Words and expressions

  (2) Unless the context otherwise requires, all other words and expressions used in this Division have the meanings assigned to them by the Food and Drug Regulations.

Fees

Marginal note:Fee for examination

6 Subject to sections 11 to 14, the fee for the examination of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission referred to in section C.08.002, C.08.002.1 or C.08.003 of the Food and Drug Regulations or an application for a drug identification number under section C.01.014.1 of those Regulations is, in respect of the submission class set out in column 1 of Schedule 1 and described in column 2, the fee set out in column 3. The fee is payable by the person who files the submission or supplement or makes the application.

Timing of Payment

Marginal note:Timing of payment — $10,000 or less

• 7 (1) If the fee referred to in section 6 is $10,000 or less, it is payable at the time that the submission or supplement is filed or the application is made.

• Marginal note:Timing of payment — more than $10,000

  (2) If the fee referred to in section 6 is more than $10,000,

  • (a) 10% of the fee is payable on receipt of a notice from the Minister stating that the submission, supplement or application has been found to be incomplete following a preliminary examination;

  • (b) 75% of the fee is payable on receipt of a notice from the Minister stating that the submission, supplement or application has been found to be complete following a preliminary examination and has been accepted for further examination; and

  • (c) 25% of the fee is payable on receipt of a notice from the Minister stating that the examination of the submission, supplement or application has been completed.

Marginal note:Remission — not accepted for examination

8 If the total amount of the fee has been paid at the time of filing in accordance with subsection 7(1) and the person referred to in section 6 receives a notice from the Minister stating that the submission, supplement or application has not been accepted for further examination, remission is granted of the amount paid less 10%, which the Minister must repay to that person.

Marginal note:Deferred payment

• 9 (1) If the person referred to in section 6 has not completed their first full fiscal year on the day on which they file the submission or make the application and if a statement signed by the individual responsible for the person’s financial affairs specifying the commencement date of that fiscal year is provided with the submission or application, the payment of the fee in respect of the submission or application is deferred for a two-year period following the day the submission is filed or application is made, together with the payment of any fee that becomes payable in respect of a supplement filed during that period. At the end of the two-year period, the person must pay all of the applicable amounts payable.

• Marginal note:Inaccurate statement

  (2) If the Minister determines, on the basis of any information available to the Minister, that a statement provided under subsection (1) is inaccurate, the payment cannot be deferred and is payable in accordance with section 7. The Minister must notify the person accordingly.

Marginal note:Deferred payment — notice of compliance

• 10 (1) If the person referred to in section 6 submits an application for authorization under section C.07.003 of the Food and Drug Regulations at the same time that it files the submission or supplement or makes the application for a drug identification number, the payment of the fee is deferred until the issuance of a notice of compliance under section C.08.004 of those Regulations or the issuance of a document setting out the drug identification number assigned for the drug under section C.01.014.2 of those Regulations.

• Marginal note:Later date

  (2) If the person is also entitled to a deferral under section 9, the payment of the fee is deferred until the later date.

Remission

Marginal note:Remission — anticipated gross revenue

• 11 (1) Subject to subsection (4) and subsection 13(2), remission is granted of the amount by which the fee payable under section 6 exceeds 10% of the actual gross revenue of a person referred to in that section if

  • (a) the person provides with their submission, supplement or application

    • (i) a statement signed by the individual responsible for the person’s financial affairs indicating the person’s anticipated gross revenue and certifying that the fee payable under section 6 is greater than an amount equal to 10% of that anticipated gross revenue,

    • (ii) information establishing that the fee payable under section 6 is greater than an amount equal to 10% of the person’s anticipated gross revenue, and

    • (iii) the amount of $500 for processing the remission; and

  • (b) on the basis of the information provided under paragraph (a) and any other information available to the Minister, the Minister determines that the fee payable under section 6 is likely to be greater than an amount equal to 10% of the person’s actual gross revenue.

• Marginal note:Amounts payable

  (2) The fee is then payable as follows:

  • (a) an amount equal to 10% of the person’s anticipated gross revenue is payable in accordance with subsection 7(2); and

  • (b) the amount, if any, by which the lesser of the fee payable under section 6 and 10% of the person’s actual gross revenue exceeds the amount paid under paragraph (a) is payable 60 days after the day on which the fee verification period ends.

• Marginal note:Sales records

  (3) Within 60 days after the end of the fee verification period, the person must provide the Minister with sales records in regard to the sales of the drug in Canada during the fee verification period, prepared in accordance with generally accepted accounting principles, and a document signed by the individual responsible for the person’s financial affairs certifying that they were so prepared.

• Marginal note:Omission

  (4) If, within 60 days after the end of the fee verification period, the person has not provided the Minister with the records referred to in subsection (3), the difference between the fee payable under section 6 and the amount already paid is immediately payable.

Marginal note:Remission — actual gross revenue

12 If the amount already paid is greater than 10% of the actual gross revenue of the person referred to in section 6, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the person.

Marginal note:Audited sales records

• 13 (1) If the Minister determines, on the basis of any information available to the Minister, that the records provided in accordance with subsection 11(3) are not adequate to determine the actual gross revenue of the person referred to in section 6, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the person to provide sales records that have been audited by a qualified independent auditor.

• Marginal note:Omission

  (2) If, within 60 days after the day of the Minister’s request for the audited sales records, the person has not provided the Minister with them, the difference between the fee payable under section 6 and the amount already paid is immediately payable.

• Marginal note:Difference payable

  (3) If the audited sales records establish that the amount already paid is less than 10% of the person’s actual gross revenue, the amount by which the lesser of the fee payable under section 6 and 10% of the person’s actual gross revenue exceeds the amount paid is immediately payable.

• Marginal note:Difference remitted

  (4) If the audited sales records establish that the amount already paid is greater than 10% of the person’s actual gross revenue, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the person.

Marginal note:Remission

14 Remission is granted to the person referred to in section 6 of the amount of the fee referred to in that section in respect of a drug if the manufacturer has received an authorization under section 21.04 of the Patent Act.

DIVISION 2Fees for the Examination of an Application for a Drug Establishment Licence

Interpretation

Marginal note:Definitions

• 15 (1) The following definitions apply in this Division.

  activity

  activité

  activity means an activity set out in Table I to section C.01A.008 of the Food and Drug Regulations. (activité)

  category

  catégorie

  category means a category of drugs set out in Table II to section C.01A.008 of the Food and Drug Regulations. (catégorie)

  drug

  drogue

  drug has the same meaning as in subsection C.01A.001(2) of the Food and Drug Regulations. (drogue)

  establishment licence

  licence d’établissement

  establishment licence means a licence issued under section C.01A.008 of the Food and Drug Regulations. (licence d’établissement)

  health care facility

  établissement de santé

  health care facility means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities. (établissement de santé)

• Marginal note:Words and expressions

  (2) Unless the context otherwise requires, all other words and expressions used in this Division have the meanings assigned to them by the Food and Drugs Act or the Food and Drug Regulations.

Application

Marginal note:Non-application

16 This Division does not apply to any publicly funded health care facility or any branch or agency of the Government of Canada or of the government of a province.

Fee

Marginal note:Fee

• 17 (1) The fee payable by an applicant for the examination of an application for an establishment licence or for the annual review of an establishment licence is the sum of the applicable fees referred to in sections 19 to 25 and the fee payable by an applicant for the examination of an application for the amendment of an establishment licence is the sum of the fees referred to in sections 27 and 28.

• Marginal note:Remission

  (2) Subject to subsection 26(2), if the fee is greater than an amount equal to 1% of the applicant’s actual gross revenue from activities conducted under an establishment licence during the previous calendar year, remission is granted of the difference between those amounts if the applicant provides with their application a statement signed by the individual responsible for the applicant’s financial affairs that sets out the actual gross revenue.

• Marginal note:Timing of payment

  (3) Subject to subsection (4), the fee is payable at the time the applicant submits an application for an establishment licence or for the annual review of an establishment licence under section C.01A.005 or C.01A.009 of the Food and Drug Regulations or an application for the amendment of an establishment licence under section C.01A.006 of those Regulations.

• Marginal note:First year of activities

  (4) If the applicant has not completed their first calendar year of conducting activities under the establishment licence, the payment of the fee is deferred until the end of that year.

• Marginal note:Reinstatement

  (5) Every provision of this Division that applies to an application for an establishment licence also applies to a request to have such a licence reinstated.

Marginal note:Interpretation

18 In sections 19 to 25, a reference to the examination of an application for an establishment licence includes an examination of an application for the annual review of an establishment licence.

Marginal note:Licence authorizing fabrication

• 19 (1) For the examination of an application for an establishment licence for each building at which one or more activities, including fabricating drugs, are to be conducted, the fee is the basic fee, set out in item 1, column 2, of Schedule 2, and any of the following fees that are applicable:

  • (a) if the licence is in respect of more than one category, for each additional category, the fee set out in item 2, column 2, of Schedule 2;

  • (b) if the licence is in respect of more than one dosage form class, the applicable fee set out in item 3, column 2, of Schedule 2;

  • (c) if the licence is in respect of sterile dosage forms, the fee set out in item 4, column 2, of Schedule 2.

• Marginal note:Importing

  (2) Despite section 21, if the importing of drugs is to be authorized by the establishment licence at a building referred to in subsection (1), the fee referred to in paragraph 21(b) is also payable.

Marginal note:Licence authorizing packaging/labelling

• 20 (1) Subject to subsection (3), for the examination of an application for an establishment licence for each building at which one or more activities, including packaging/labelling drugs but not including fabricating drugs, are to be conducted, the fee is the basic fee, set out in item 1, column 2, of Schedule 3, and any of the following fees that are applicable:

  • (a) if the licence is in respect of more than one category, for each additional category, the fee set out in item 2, column 2, of Schedule 3;

  • (b) if the licence is in respect of more than one dosage form class, the applicable fee set out in item 3, column 2, of Schedule 3.

• Marginal note:Importing

  (2) Despite section 21, if the importing of drugs is to be authorized by the establishment licence at a building referred to in subsection (1), the fee referred to in paragraph 21(b) is also payable.

• Marginal note:Medical gas

  (3) If the applicant for an establishment licence proposes to conduct activities only in regard to drugs in the dosage form class of medical gas at more than one building, the fee is the sum of the following fees:

  • (a) in regard to packaging/labelling, the basic fee set out in item 1, column 2, of Schedule 3, as if only one building were authorized under the licence;

  • (b) in regard to all other activities, the fee that would be payable under subsection 17(1) if packaging/labelling activities were not referred to in the application.

Marginal note:Licence authorizing importation

21 If one or more activities, including importing drugs but not including fabricating or packaging/labelling drugs, are referred to in the application for an establishment licence, the fee for the examination of that application is

• (a) for each building at which those activities are to be conducted, the basic fee, set out in item 1, column 2, of Schedule 4, and any of the following fees that are applicable:

  • (i) if the licence is in respect of more than one category, for each additional category, the fee set out in item 2, column 2, of Schedule 4,

  • (ii) if the licence is in respect of more than one dosage form class, the applicable fee set out in item 3, column 2, of Schedule 4; and

• (b) for each fabricator outside Canada of drugs that are to be imported, except if the importer provides a certificate from a Canadian inspector indicating that the fabricator’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4 of Part C of the Food and Drug Regulations, the sum of the following fees that are applicable:

  • (i) the fee set out in item 4, column 2, of Schedule 4,

  • (ii) if the licence is in respect of more than one dosage form class, for each additional dosage form class, the fee set out in item 5, column 2, of Schedule 4.

Marginal note:Licence authorizing distribution

22 For the examination of an application for an establishment licence for each building at which one or more activities — including distributing drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations but not including fabricating, packaging/labelling or importing drugs — are to be conducted, the fee is the basic fee, set out in item 1, column 2, of Schedule 4, and any of the following fees that are applicable:

• (a) if the licence is in respect of more than one category, for each additional category, the fee set out in item 2, column 2, of Schedule 4;

• (b) if the licence is in respect of more than one dosage form class, the applicable fee set out in item 3, column 2, of Schedule 4.

Marginal note:Licence authorizing distribution or wholesaling

23 For the examination of an application for an establishment licence for each building at which one or more activities — including distributing drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations or wholesaling drugs but not including fabricating, packaging/labelling or importing drugs or distributing drugs as a distributor referred to in paragraph C.01A.003(b) of those Regulations — are to be conducted, the fee is a basic fee of $3,870.

Marginal note:Licence authorizing testing

24 For the examination of an application for an establishment licence for each building at which only the testing of drugs is to be conducted, the fee is a basic fee of $2,580.

Marginal note:Drug analysis fee

25 In addition to the fees referred to in sections 19 to 22, if the application for an establishment licence seeks to authorize the holder to fabricate, package/label or import drugs or distribute drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, the fee is the highest fee set out in column 2 of Schedule 5 that corresponds to the drugs described in column 1

• (a) in respect of which the licence is requested; and

• (b) for which the holder has obtained a drug identification number, except in the case of an importer.

Marginal note:Audited sales records

• 26 (1) If the Minister determines, on the basis of any information available to the Minister, that the statement provided under subsection 17(2) is not adequate to determine the applicant’s actual gross revenue referred to in that subsection, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the applicant to provide sales records that have been audited by a qualified independent auditor.

• Marginal note:Omission

  (2) If, within 60 days after the day of the Minister’s request for the audited sales records, the applicant has not provided the Minister with them, the difference between the fee payable under subsection 17(1) and the amount already paid is immediately payable.

• Marginal note:Difference payable

  (3) If the audited sales records establish that the amount already paid is less than the amount payable under section 17, the difference between those amounts is immediately payable.

• Marginal note:Difference remitted

  (4) If the audited sales records establish that the amount already paid is greater than the amount payable under section 17, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the applicant.

Licence Amendment

Marginal note:Sterile dosage forms

27 If the application to amend an establishment licence authorizing the holder to conduct one or more activities including fabricating drugs seeks to authorize the holder to fabricate drugs in sterile dosage forms for the first time at a building, the fee for the examination of the application is the basic fee set out in item 1, column 2, of Schedule 2 for each building referred to in the application.

Marginal note:Activity

• 28 (1) If an application to amend an establishment licence seeks to add an activity at a building, the fee for the examination of the application for each building at which the activity is to be added is,

  • (a) if the amendment seeks to authorize the holder to fabricate drugs, the basic fee set out in item 1, column 2, of Schedule 2;

  • (b) if the amendment seeks to authorize the holder to package/label drugs but not to fabricate drugs, the basic fee set out in item 1, column 2, of Schedule 3;

  • (c) if the amendment seeks to authorize the holder to import drugs but not to fabricate or package/label drugs, the basic fee set out in item 1, column 2, of Schedule 4;

  • (d) if the amendment seeks to authorize the holder to distribute drugs as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations but not to fabricate, package/label or import drugs, the basic fee set out in item 1, column 2, of Schedule 4; and

  • (e) if the amendment seeks to authorize the holder to distribute drugs as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations, or to wholesale drugs or to conduct both of those activities, but not to fabricate, package/label or import drugs or to distribute drugs as a distributor referred to in paragraph C.01A.003(b) of those Regulations, the basic fee set out in section 23.

• Marginal note:Category

  (2) Subject to subsection (3), if an application to amend an establishment licence seeks to add a category in respect of an activity that is authorized by the licence at a building, the fee for the examination of the application for each building at which the category is to be added is,

  • (a) if the amendment seeks to authorize the holder to fabricate a drug of an additional category, the basic fee set out in item 1, column 2, of Schedule 2;

  • (b) if the amendment seeks to authorize the holder to package/label a drug of an additional category, the basic fee set out in item 1, column 2, of Schedule 3;

  • (c) if the amendment seeks to authorize the holder to import a drug of an additional category, the basic fee set out in item 1, column 2, of Schedule 4;

  • (d) if the amendment seeks to authorize the holder to distribute a drug of an additional category as a distributor referred to in paragraph C.01A.003(b) of the Food and Drug Regulations, the basic fee set out in item 1, column 2, of Schedule 4;

  • (e) if the amendment seeks to authorize the holder to distribute a drug of an additional category as a distributor referred to in paragraph C.01A.003(a) of the Food and Drug Regulations or to wholesale a drug of an additional category, the basic fee set out in section 23; and

  • (f) if the amendment seeks to authorize the holder to test a drug of an additional category, the basic fee set out in section 24.

• Marginal note:Included categories

  (3) If an application to amend an establishment licence seeks to add a category in respect of more than one activity referred to in paragraphs (2)(a) to (f), the fee payable under subsection (2) for the examination of the application is the highest applicable fee for those activities.

DIVISION 3Fees for the Examination of Dealer’s Licence Applications

Interpretation

Marginal note:Definitions

• 29 (1) The following definitions apply in this Division.

  controlled drug

  controlled drug has the same meaning as in subsection G.01.001(1) of the Food and Drug Regulations. (drogue contrôlée)

  dealer’s licence

  dealer’s licence means

  • (a) a licence issued under section G.02.003.2 of the Food and Drug Regulations; or

  • (b) a licence issued under section 9.2 of the Narcotic Control Regulations. (licence de distributeur autorisé)

  health care facility

  health care facility means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities. (établissement de santé)

  narcotic

  narcotic has the same meaning as in section 2 of the Narcotic Control Regulations. (stupéfiant)

• Marginal note:Words and expressions

  (2) Unless the context otherwise requires, all other words and expressions used in this Division have the meanings assigned to them by the Controlled Drugs and Substances Act, Part G of the Food and Drug Regulations or the Narcotic Control Regulations.

Application

Marginal note:Non-application

30 This Division does not apply to

• (a) any publicly funded health care facility;

• (b) any branch or agency of the Government of Canada or of the government of a province; or

• (c) any person or organization engaged only in scientific investigation.

Fees

Marginal note:Fee — Dealer’s licence

• 31 (1) The fee payable by an applicant for the examination of an application for either a dealer’s licence or the renewal of a dealer’s licence is $4,510 for each of the premises at which activities are to be conducted under the licence.

• Marginal note:Remission

  (2) Subject to section 32 and subsection 33(2), if the fee is greater than an amount equal to 1% of the applicant’s actual gross revenue from activities conducted under a dealer’s licence during the previous calendar year, remission is granted of the difference between those amounts if the applicant provides with their application a statement signed by the individual responsible for the applicant’s financial affairs that sets out the actual gross revenue.

• Marginal note:Timing of payment

  (3) Subject to subsection (4), the fee is payable at the time of submitting the application for a dealer’s licence or for the renewal of a dealer’s licence under section 9 or 9.5 of the Narcotic Control Regulations or section G.02.003 or G.02.003.4 of the Food and Drug Regulations.

• Marginal note:First year of activities

  (4) If the applicant has not completed their first calendar year of conducting activities under the licence, the payment of the fee is deferred until the end of that year.

Marginal note:Remission — dealer’s licence and establishment licence

32 Remission is granted of an amount equal to the difference between the total of the fees payable under subsections 17(1) and 31(1) and an amount equal to 1% of the applicant’s actual gross revenue referred to in paragraph (a) if

• (a) the total of the fees payable under those subsections is greater than an amount equal to 1% of the applicant’s actual gross revenue from activities conducted under their dealer’s licence during the previous calendar year;

• (b) the dealer’s licence and the establishment licence were issued to the same holder and are related to the same activities conducted at the same premises;

• (c) remission has not been granted under subsection 17(2) nor under subsection 31(2); and

• (d) the applicant has provided the statement referred to in subsection 31(2).

Marginal note:Audited sales records

• 33 (1) If the Minister determines, on the basis of any information available to the Minister, that the statement provided under subsection 31(2) is not adequate to determine the applicant’s actual gross revenue referred to in that subsection, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the applicant to provide sales records that have been audited by a qualified independent auditor.

• Marginal note:Omission

  (2) If, within 60 days after the day of the Minister’s request for the audited sales records, the applicant has not provided the Minister with them, the difference between the fee payable under subsection 31(1) and the amount already paid is immediately payable.

• Marginal note:Difference payable

  (3) If the audited sales records establish that the amount already paid is less than the amount payable under section 31, the difference between those amounts is immediately payable.

• Marginal note:Difference remitted

  (4) If the audited sales records establish that the amount already paid is greater than the amount payable under section 31, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the applicant.

DIVISION 4Fees for Right to Sell Drugs

Interpretation

Marginal note:Words and expressions

34 The words and expressions used in this Division have the meanings assigned to them by the Food and Drugs Act or the Food and Drug Regulations.

Fee

Marginal note:Annual fee

• 35 (1) The annual fee that is payable by a manufacturer for the right to sell a drug for which a drug identification number has been assigned under section C.01.014.2 of the Food and Drug Regulations is $1,020.

• Marginal note:Remission — actual gross revenue

  (2) Subject to subsection 36(2), if the fee is greater than an amount equal to 1.5% of the actual gross revenue from the sale of the drug in Canada during the previous calendar year, remission is granted of the difference between those amounts if the manufacturer provides with the notification referred to in subsection (3) a statement signed by the individual responsible for the manufacturer’s financial affairs that sets out the actual gross revenue.

• Marginal note:Timing of payment

  (3) Subject to subsection (4), the fee is payable at the time the manufacturer furnishes the notification under section C.01.014.5 of the Food and Drug Regulations.

• Marginal note:First year of activities

  (4) If the manufacturer has not completed its first calendar year of selling the drug, the payment of the fee is deferred until the end of that year.

Marginal note:Audited sales records

• 36 (1) If the Minister determines, on the basis of any information available to the Minister, that the statement provided under subsection 35(2) is not adequate to determine the actual gross revenue from the sale of the drug in Canada during the previous calendar year, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the manufacturer to provide sales records that have been audited by a qualified independent auditor.

• Marginal note:Omission

  (2) If, within 60 days after the day of the Minister’s request for the audited sales records, the manufacturer has not provided the Minister with them, the difference between the fee payable under subsection 35(1) and the amount already paid is immediately payable.

• Marginal note:Difference payable

  (3) If the audited sales records establish that the amount already paid is less than the amount payable under section 35, the difference between those amounts is immediately payable.

• Marginal note:Difference remitted

  (4) If the audited sales records establish that the amount already paid is greater than the amount payable under section 35, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the manufacturer.

PART 3Medical Device Fees

DIVISION 1Interpretation

Marginal note:Definitions

• 37 (1) The following definitions apply in this Part.

  actual gross revenue

  actual gross revenue means the amount earned by a manufacturer during the fee verification period from sales in Canada of a medical device that is the subject of a licence application that is referred to in section 39, 40 or 41. (recettes brutes réelles)

  annual gross revenue

  annual gross revenue means

  • (a) in section 48, the amount earned by a manufacturer during a calendar year from sales in Canada of a medical device in respect of which the manufacturer holds a licence; and

  • (b) in sections 51 and 52, the amount earned by an establishment during a calendar year from sales in Canada of medical devices. (recettes brutes annuelles)

  anticipated gross revenue

  anticipated gross revenue means the amount that a manufacturer expects to earn during the fee verification period from sales in Canada of the medical device that is the subject of a licence application that is referred to in section 39, 40 or 41. (recettes brutes prévues)

  fee verification period

  fee verification period, in respect of a medical device that is the subject of a licence application that is referred to in section 39, 40 or 41, means the period beginning on the day on which the medical device is first sold in Canada under the licence and ending two years after that day. (période de vérification du prix à payer)

• Definition of licence

  (2) In this Division and Divisions 2 and 3, licence means a medical device licence issued under paragraph 36(1)(a) of the Medical Devices Regulations.

• Marginal note:Words and expressions

  (3) Unless the context otherwise requires, all other words and expressions used in this Part have the meanings assigned to them by the Food and Drugs Act or the Medical Devices Regulations.

DIVISION 2Fees for the Examination of Medical Device Licence Applications

Application

Marginal note:Applicable classes

• 38 (1) This Division applies to medical devices that are subject to the Medical Devices Regulations, other than devices that are subject to Part 2 or 3 of those Regulations, and that are classified into one of Classes II to IV under sections 6 and 7 of those Regulations.

• Marginal note:Private label

  (2) This Division does not apply to a medical device that is identical in every respect to a medical device for which a licence has been issued except that the device is labelled with the name and address of another manufacturer and the name and identifier of the device that that other manufacturer is proposing to sell under its own name or under a trade-mark, design, trade name or other name or mark owned or controlled by it.

Class II Medical Device Licence

Marginal note:Fee — Class II medical device

• 39 (1) The fee for the examination of an application for a licence for a Class II medical device submitted in accordance with section 32 of the Medical Devices Regulations is $350 and is payable by the manufacturer at the time that the application is submitted.

• Marginal note:Reinstatement of a Class II medical device licence

  (2) Every provision of this Division that applies to an application for a licence for a Class II medical device submitted in accordance with section 32 of the Medical Devices Regulations also applies to a request to have such a licence reinstated.

Class III or IV Medical Device Licence

Marginal note:Fee — Class III or IV medical device

• 40 (1) The fee that is payable by a manufacturer for the examination of an application for a licence for a Class III or IV medical device submitted in accordance with section 32 of the Medical Devices Regulations is

  • (a) in the case of a Class III medical device, for each category set out in column 1 of Schedule 6, the fee set out in column 2; or

  • (b) in the case of a Class IV medical device, for each category set out in column 1 of Schedule 7, the fee set out in column 2.

• Marginal note:Reinstatement of Class III or IV medical device licence

  (2) Every provision of this Division that applies to an application for a licence for a Class III or IV medical device submitted in accordance with section 32 of the Medical Devices Regulations also applies to a request to have such a licence reinstated.

Class III or IV Medical Device Licence Amendment

Marginal note:Fee — amendment to medical device licence

41 The fee that is payable by a manufacturer for the examination of an application for a licence amendment submitted in accordance with paragraph 34(a) or (b) of the Medical Devices Regulations is

• (a) in the case of a Class III medical device, the amount obtained by adding, for each category set out in column 1 of Schedule 6, the fee set out in column 2; or

• (b) in the case of a Class IV medical device, the amount obtained by adding, for each category set out in column 1 of Schedule 7, the fee set out in column 2.

Timing of Payment

Marginal note:Timing of payment

42 If the fee that is payable under section 40 or 41 is

• (a) $5,000 or less, the fee is payable at the time that the application is submitted; or

• (b) more than $5,000, the fee is payable as follows:

  • (i) 10% on receipt of a notice from the Minister stating that the application has been found to be incomplete following a preliminary examination,

  • (ii) 75% on receipt of a notice from the Minister stating that the application has been found to be complete following a preliminary examination and has been accepted for further examination, and

  • (iii) 25% on receipt of a notice from the Minister stating that the examination of the application has been completed.

Deferred Payment

Marginal note:Deferred payment

• 43 (1) If a manufacturer has not completed its first full fiscal year on the day on which it submits its licence application and if a statement signed by the individual responsible for the manufacturer’s financial affairs specifying the commencement date of that fiscal year is provided with the application, the payment of the fee in respect of the application is deferred for a period of one year following the day the application was submitted, together with the payment of any fee that becomes payable in respect of an application for a licence amendment submitted during that period. At the end of the one-year period, the manufacturer must pay all of the amounts payable.

• Marginal note:Inaccurate statement

  (2) If the Minister determines, on the basis of any information available to the Minister, that a statement provided under subsection (1) is inaccurate, the payment cannot be deferred and is payable in accordance with section 42. The Minister must notify the manufacturer accordingly.

Remission

Marginal note:Remission — anticipated gross revenue

• 44 (1) Subject to subsection (4) and subsection 46(2), remission is granted of the amount by which the fee payable under section 39, 40 or 41, as applicable, exceeds 2.5% of the actual gross revenue from a medical device if that revenue is $100,000 or less and if

  • (a) the manufacturer provides with their licence application

    • (i) a statement signed by the individual responsible for the manufacturer’s financial affairs indicating that the anticipated gross revenue is $100,000 or less and certifying that the fee payable under section 39, 40 or 41, as applicable, is greater than an amount equal to 2.5% of that anticipated gross revenue,

    • (ii) information establishing that the fee payable under section 39, 40 or 41, as applicable, is greater than an amount equal to 2.5% of the anticipated gross revenue, and

    • (iii) the amount of $50 for processing the remission, except in the case of the remission of a fee payable under section 39; and

  • (b) on the basis of the information provided under paragraph (a) and any other information available to the Minister, the Minister determines that the actual gross revenue will be $100,000 or less and that the fee payable under section 39, 40 or 41, as applicable, is likely to be greater than an amount equal to 2.5% of the actual gross revenue.

• Marginal note:Amounts payable

  (2) The fee is then payable as follows:

  • (a) an amount equal to 2.5% of the anticipated gross revenue is payable in accordance with section 39 or 42, as applicable; and

  • (b) the amount, if any, by which the lesser of the fee referred to in section 39, 40 or 41, as applicable, and 2.5% of the actual gross revenue exceeds the amount paid under paragraph (a) is payable 60 days after the day on which the fee verification period ends.

• Marginal note:Sales records

  (3) Within 60 days after the end of the fee verification period, the manufacturer must provide the Minister with sales records in regard to the sales of the medical device in Canada during the fee verification period, prepared in accordance with generally accepted accounting principles, and a document signed by the individual responsible for the manufacturer’s financial affairs certifying that they were so prepared.

• Marginal note:Omission

  (4) If, within 60 days after the end of the fee verification period, the manufacturer has not provided the Minister with the sales records, the difference between the fee referred to in section 39, 40 or 41, as applicable, and the amount already paid is immediately payable.

Marginal note:Remission — actual gross revenue

45 If the amount paid under section 44 is greater than an amount equal to 2.5% of the manufacturer’s actual gross revenue from the medical device and that revenue is $100,000 or less, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the manufacturer.

Marginal note:Audited sales records

• 46 (1) If the Minister determines, on the basis of any information available to the Minister, that the records provided in accordance with subsection 44(3) are not adequate to determine the manufacturer’s actual gross revenue, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the manufacturer to provide sales records that have been audited by a qualified independent auditor.

• Marginal note:Omission

  (2) If, within 60 days after the day of the Minister’s request for the audited sales records, the manufacturer has not provided the Minister with them, the difference between the amount already paid and the fee referred to in section 39, 40 or 41, as applicable, is immediately payable.

• Marginal note:Difference payable

  (3) If the audited sales records establish that the amount already paid is less than the amount payable under section 44, the difference between those amounts is immediately payable.

• Marginal note:Difference remitted

  (4) If the audited sales records establish that the amount already paid is greater than the amount payable under section 44, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the manufacturer.

Marginal note:Remission — General Council Decision

47 Remission is granted to the manufacturer of the amount of the fee referred to in section 39, 40 or 41, as applicable, in respect of a medical device if the manufacturer has received an authorization under section 21.04 of the Patent Act.

DIVISION 3Fee for Right to Sell Licensed Class II, III or IV Medical Devices

Marginal note:Fee

• 48 (1) The annual fee that is payable by a manufacturer for the right to sell a Class II, III or IV medical device for which the manufacturer holds a licence is

  • (a) $50 if its annual gross revenue from the sales of that medical device and any other medical devices in the same medical device family during the previous calendar year is less than $20,000 and if it provides a statement certifying that fact that is signed by the individual responsible for its financial affairs; and

  • (b) $330 in any other case.

• Marginal note:Timing of payment

  (2) Subject to subsection (3), the fee is payable at the time the manufacturer furnishes the statement referred to in subsection 43(1) of the Medical Devices Regulations.

• Marginal note:First year of activities

  (3) If the manufacturer has not completed its first calendar year of selling the medical device, the payment of the fee is deferred until the end of that year.

Marginal note:Audited sales records

• 49 (1) If the Minister determines, on the basis of any information available to the Minister, that the statement provided in accordance with paragraph 48(1)(a) is inaccurate, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the manufacturer to provide sales records that have been audited by a qualified independent auditor.

• Marginal note:Omission

  (2) If, within 60 days after the day of the Minister’s request for the audited sales records, the manufacturer has not provided the Minister with them, the difference between the fee specified in paragraph 48(1)(b) and the amount already paid is immediately payable.

• Marginal note:Difference payable

  (3) If the audited sales records establish that the amount paid under paragraph 48(1)(a) was incorrect, the difference between the fee specified in paragraph 48(1)(b) and the amount already paid is immediately payable.

DIVISION 4Fees for the Examination of an Application for an Establishment Licence

Application

Marginal note:Applicable classes

50 This Division applies to establishments that import or sell medical devices that are subject to the Medical Devices Regulations, except establishments that import or sell only medical devices that are subject to Part 2 or 3 of those Regulations.

Fee

Marginal note:Fee

• 51 (1) The fee payable by an establishment for the examination of an application for an establishment licence or for the annual review of such a licence or in respect of the reinstatement of such a licence at the request of the holder following the correction of the situation that gave rise to its suspension is $7,200.

• Marginal note:Remission

  (2) Subject to subsection 52(2), if the fee is greater than an amount equal to 1% of the establishment’s annual gross revenue during the previous calendar year, remission is granted of the difference between those amounts if the establishment provides with its application or request a statement signed by the individual responsible for the establishment’s financial affairs that sets out the annual gross revenue.

• Marginal note:Timing of payment

  (3) Subject to subsection (4), the fee is payable at the time the application for the establishment licence or for the annual review of such a licence is submitted or at the time the licence is reinstated.

• Marginal note:First year of activities

  (4) If the establishment has not completed its first calendar year of conducting activities under the establishment licence, the payment of the fee is deferred until the end of that year.

Verification of Annual Gross Revenue

Marginal note:Audited sales records

• 52 (1) If the Minister determines, on the basis of any information available to the Minister, that the statement provided under subsection 51(2) is not adequate to determine the establishment’s annual gross revenue, the Minister may require, for the purpose of determining the fee payable or the amount of the remission, the establishment to provide sales records that have been audited by a qualified independent auditor.

• Marginal note:Omission

  (2) If, within 60 days after the day of the Minister’s request for the audited sales records, the establishment has not provided the Minister with them, the difference between the fee payable under subsection 51(1) and the amount already paid is immediately payable.

• Marginal note:Correct fee payable on verification

  (3) If the audited sales records establish that the amount already paid is less than the amount payable under section 51, the difference between those amounts is immediately payable.

• Marginal note:Remission

  (4) If the audited sales records establish that the amount already paid is greater than the amount payable under section 51, remission is granted of an amount equal to the difference between those amounts, which the Minister must repay to the establishment.

PART 4Transitional Provision, Repeals and Coming into Force

Transitional Provision

Marginal note:Fee for prior application

53 The fee for the examination of an application, submission or supplement that is filed before the coming into force of these Regulations is the fee that is specified by the applicable regulation that is in effect at the time of filing.

Repeals

54 [Repeal]

55 [Repeal]

Coming into Force

Marginal note:Registration

56 These Regulations come into force on April 1, 2011, but if they are registered after that day, they come into force on the day on which they are registered.